LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K991316
    Device Name
    TOUCH TEAR IGE MICROASSAY KIT
    Manufacturer
    TOUCH SCIENTIFIC, INC.
    Date Cleared
    1999-08-09

    (112 days)

    Product Code
    DGC
    Regulation Number
    866.5510
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOUCH SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TOUCH TEAR IGE MICROASSAY KIT™ is an in vitro diagnostic device which is used for the quantitative determination of Immunoglobulin E (IgE) concentration in human tears. This can be used as an aid in the diagnosis of ocular Type 1 allergic conjunctivitis or the allergic component of ocular inflammatory responses.
    Device Description
    Not Found
    Ask a Question

    Page 1 of 1